Kornimate/medical-research-clean huggingface dataset:
manual therapy in metabolic liver disease

Conditions: NAFLD, Non-alcoholic Fatty Liver Disease

Summary: hepatic steatosis is a disease that is becoming more common in our society; approximately 40% of the population suffers from non-alcoholic fatty liver. the beneficial effect of manual therapy for the treatment of viscera dysfunctions such as the stomach or colon is known. the objective of this study is to demonstrate the anti-inflammatory effects of visceral manual therapy in patients with metabolic liver disease associated with non-alcoholic fatty liver.

chronic liver diseases such as metabolic disease associated with nonalcoholic fatty liver lead to a stiff liver due to activation of hepatic stellate cells or portal fibroblasts into matrix-producing myofibroblasts. congested livers tend to fibrosis, while the physiological forces that the liver receives during physical activity and deep breathing could have a beneficial effect on it, favoring physiological remodeling. the importance of the mobility of the viscera for their proper functioning is known. likewise, the beneficial effect of physical activity on the liver is known. this physical activity includes a component of applying pressure on the liver. these pressures are also exerted during the techniques described for manual liver treatment. although there is some evidence about the effectiveness of these manual techniques for the treatment of pain situations, the effect they could have on liver parameters is unknown. for all these reasons, we aim to know the effect of manual liver techniques on biochemical and mechanical sensitivity parameters in subjects with metabolic disease associated with non-alcoholic fatty liver (nafld).

Eligibility criteria:
inclusion criteria: * patients over 18 years of age with methd defined by an ultrasound compatible with hepatic steatosis and an hsi \> 36 exclusion criteria: * fibrosis defined by fib-4 \> 2.67 * hepatic cirrhosis * geographic dispersion to avoid losses * contraindication to manual therapy * diabetes mellitus tiype 1 * severe hypertriglyceridemia with tg \> 500 mg/dl at the time of recruitment * life expectancy less than one year * advanced chronic kidney disease (stage g4)
effect of intraocular tamponade on visual perception

Conditions: Retinal Detachment; Optic Neuropathy; Glaucoma

Summary: intraocular tamponade used in vitrectomy operations may affects retinal function in various mechanisms.

various intraocular tamponade are being used in vitrectomy operations as gases, fluids and silicon oil. the effects of these intraocular tamponade may affects the final visual outcome of the surgery.

Eligibility criteria:
inclusion criteria: * primary retinal detachment patients. * patients eligible for 23 gauge pars-plana vitrectomy operation. exclusion criteria: * patients with axial length more than 30 millimeter that may have severe chorioretinal degenerations that may affects retinal function. * patients with macular diseases that may affects final visual outcome as macular holes and choroidal neovascular membranes.

Keywords: vitrectomy retinal detachment intraocular tamponade silicon oil air tamponade
weight trajectory in new users of sulfonylureas as add on therapy next to metformin.

Conditions: Type 2 Diabetes Mellitus

Summary: next to hba1c, body weight is regarded as an important surrogate end-point in trials investigating glucose-lowering agents. an increase in weight could contribute to worsening insulin resistance. differences in weight after starting glucose lowering agents have been described in many randomized controlled trials (rcts). with this prospective observational study, weight trajectories after receiving add-on therapy next to metformin are evaluated in primary care patients with good glycaemic control.

this prospective cohort study is part of the zodiac (zwolle outpatient diabetes project integrating available care) study, which started in 1998 as a prospective observational study and includes patients with known t2dm who are treated in primary care. the investigators aim to investigate the course of the bodyweight and glycaemic control, the years after starting specific su's, pioglitazone or insulin as add-on therapy, in metformin treated primary care patients with t2dm. as part of the process called benchmarking, a dataset of quality measures is collected annually for all patients participating in the zodiac study during the patient's visit to the practice nurse and/or general practitioner and sent to the investigators' diabetes centre for benchmarking and research purposes once a year.

Eligibility criteria:
inclusion criteria: * t2dm * treated in primary care in period 1998 to 2012 * used metformin monotherapy * subsequently received add-on therapy with a su or pioglitazone during their entire follow-up period

Keywords: type 2 diabetes new-user design weight trajectory add-on therapy sulphonylureas.
: external shunt versus internal shunt for off pump glenn

Conditions: Cerebral Ischemia

Summary: a prospective, randomized comparative study where investigators present results of off pump bidirectional glenn operation done using either a venoatrial shunt or external shunt to decompress superior vena cava during clamping.

the bidirectional glenn shunt (bdg) is performed for cyanotic congenital heart defects, with single-ventricle pathology . the bdg is usually performed with cardiopulmonary bypass (cpb) with its associated complications. the conduct of this operation without cpb can be associated with elevation of superior vena caval (svc) pressure that may lead to neurological damage. however, the safety of performing bdg without cpb reported by many authors but with some decompression techniques of the svc at the time of clamping objective: investigators present results of off pump bidirectional glenn operation done using either a venoatrial shunt or external shunt to decompress superior vena cava during clamping. design a prospective, randomized comparative study setting: single tertiary care cardiac center participants 30 patients with functional single ventricle who will go off pump bidirectional glenn. interventions: the patients will be randomly assigned into two groups: group i (n = 15), where it will be done with a veno-atrial shunt(internal), and group ii (n = 15), where it will be done with an external shunt. all patients will go a complete neurological examination both preoperatively as well as postoperatively intraoperative data will be collected and analyzed at the following time points: pre-clamping (post induction), during clamping and after de-clamping of svc. variables such as arterial oxygen saturation (sao2), systolic blood pressure (sbp), mean arterial blood pressure (map), diastolic blood pressure (dbp), and hematocrit, cvp, svc pressure, cerebral perfusion pressure (cpp= map-cvp), pao2, paco2 and scvo2 will be analyzed. postoperatively, the patients will be stabilized in the intensive care unit (icu) and after monitoring the svc pressure for 12 h, the internal jugular vein cannula will be removed to prevent any jugular vein thrombosis. the patients will start aspirin (5 mg/kg/day), which will be continued indefinitely.

Eligibility criteria:
inclusion criteria: * single-ventricle lesions, * good sized branch pulmonary arteries (magoon's index \> 1.5), * pa pressures \< 20 mmhg, * so2 \< 80%, * age range from (6 months-5years) * weight range from (6-21) kg, -all these patients had adequate atrial septal defects and none of these patients required any intra cardiac repair.- exclusion criteria: * previous cardiac operation, * known intracranial pathology, * neurologic disease * craniofacial anomalies.
enhancing exposure therapy for post-traumatic stress disorder

Conditions: Chronic Posttraumatic Stress Disorder

Summary: this study is investigating a new brief psychotherapy for post-traumatic stress disorder (ptsd) which, modifies an already proven psychotherapy for ptsd by adding two new components and modifying several others. the goal of the study is to determine whether this experimental treatment outperforms the well-established standard treatment.

this study is investigating a new brief psychotherapy for post-traumatic stress disorder (ptsd) which, modifies an already proven psychotherapy for ptsd by adding two new components and modifying several others. the goal of the study is to determine whether this experimental treatment outperforms the well-established standard treatment. individuals between the ages of 18-65 with chronic ptsd are randomly assigned to one of three psychotherapy conditions: (a) brief enhanced exposure therapy; (b) standard prolonged exposure therapy; and (c) delayed standard exposure therapy. all study participants undergo a phone and face-to-face screening assessment to determine study eligibility and baseline (pretreatment-week 0) symptom severity. upon completing treatment, participants undergo three additional assessment visits (week 6, week 10, and week 22). during each of these outcome assessment visits, participants complete a structured clinical interview and a battery of computer-administered questionnaires.

Eligibility criteria:
inclusion criteria: 1. current primary ptsd diagnosis based on dsm-iv criteria, with a minimum duration of 12 weeks since the traumatic event. 2. between the age of 18 and 65. 3. medication status stable for at least 6 weeks exclusion criteria: 1. current diagnosis of schizophrenia, delusional disorder, or organic mental disorder as defined by the dsm-iv. 2. current diagnosis of bipolar disorder, depression with psychotic features, or depression severe enough to require immediate psychiatric treatment (i.e., serious suicide risk with intent and plan). 3. current diagnosis of alcohol or substance dependence within the 3 previous months. 4. unwilling or unable to discontinue current trauma-focused psychotherapy. 5. ongoing intimate relationship with the perpetrator (in assault-related ptsd cases). 6. other severe acute or chronic medical or psychiatric condition that, in the judgment of the medical director, would make the participant inappropriate for entry.

Keywords: ptsd posttraumatic stress disorder exposure therapy prolonged exposure fear memory retrieval compound extinction deepened extinction psychotherapy
selective immunotargeting of pathogenic cd8 t cells of type 1 diabetes patients

Conditions: Type I Diabetes

Summary: it is well established that cd8 and cd4 t cells reactive against defined islet antigens are associated with initiation and progression of type 1 diabetes (t1d). in previous work, we have demonstrated that it is possible to redirect t cells against pathogenic t cells via chimeric peptide/mhc/cd3-zeta receptors in a peptide-specific manner and to prevent, or inhibit diabetes in nod mice. in this study we intend to extend this approach to t cells of t1d patients. working hypothesis: beta cell-reactive cd8 t cells of human t1d patients can be immuno-targeted by their own gene-modified cytotoxic t lymphocytes (ctls). aims: our major aim is to demonstrate, in a set of ex-vivo experiments, such immunotargeting with t cells derived from t1d patients at the ziv medical center. to this end we will stimulate and expand autoreactive cd8 cells in blood samples of t1d patients and target them, ex-vivo, with genetically-reprogrammed ctls which are present in the same blood samples.

to obtain proof-of-principle of our approach we have initiated tight collaboration between the laboratory of immunology at migal galilee research institute, kiryat shmona (migal) and breinin center for type 1 diabetes and endocrinology at the ziv medical center in safed (ziv). in this study we will first identify carriers of the hla-a0201 allele among pediatric and young adult t1d patients at ziv. we will then screen the t cell pool in the peripheral blood samples of these patients for cd8 t cells reactive against any of 3 known hla-a0201-binding peptides associated with autoreactivity in t1d: insulin beta chain 10-18, igrp 265-73 and igrp 222-230. the influenza virus-derived peptide mp 58-66 will serve as reference. next we will isolate polyclonal cd8 t cells from blood samples of the same patients, activate and expand them ex-vivo and transfect them via electroporation with in-vitro-transcribed mrna encoding the respective peptide/mhc/cd3-zeta construct(s). we will then perform co-culture experiments assessing the ability of the mrna-transfected t cells to kill the autoreactive t cells of the same patient in a peptide-selective manner.

Eligibility criteria:
inclusion criteria: * children and young adults, ages between 0-25 who were diagnosed with t1d no more than 3 years prior to enrollment. exclusion criteria: * none

Keywords: type 1 diabetes autoreactive t cells beta cell peptides genetically modified t cells mrna electroporation
prochymal expanded access treatment for pediatric patients who have failed steroids for acute gvhd

Conditions: Graft vs Host Disease; Graft-Versus-Host Disease

Summary: this protocol allows for the treatment of pediatric patients, male and female, between the ages of 2 months and 17 years. patients must have failed steroid treatment for grade b-d acute gvhd.

for the treatment of pediatric patients who have failed to respond to steroid treatment for acute graft-versus-host disease (gvhd). failing steroid treatment for acute gvhd is defined as any grade b-d (ibmtr grading) of acute gvhd that is not improving after at least 3 days of methylprednisolone (≥ 1 mg/kg/day) or equivalent. patients will be treated with prochymal twice per week at a dose of 2 x 10\^6 hematopoietic stem cells (hmsc)/kg (actual body weight) for each of 4 consecutive weeks. infusions will be administered at least 3 days apart.

Eligibility criteria:
inclusion criteria: * patients must sign an informed consent form (icf) before any protocol-related procedures, including any pre-treatment procedures, are performed. * since patients being treated with prochymal® under this protocol are under 18, a parental signature of informed consent will be required. * patients must be 2 months to 17 years of age, inclusive. * patients must have failed to respond to steroid treatment for grades b-d acute gvhd • failure to respond to steroid treatment for acute gvhd is defined as any grade b-d acute gvhd that is not improving after at least 3 days of methylprednisolone (≥1 milligram per kilogram per day \[mg/kg/day\]) or equivalent. exclusion criteria: * patient must not have a known allergy to bovine or porcine products. * patient must not have received a transplant for a solid tumor disease. * patients must not have evidence of a pulmonary infiltrate or diffuse alveolar hemorrhage and must be unlikely to require more than 2 liters (l) of oxygen via face mask or an estimated fraction of inspired oxygen (fio2) of 28% via other delivery methods in order to sustain an o2 saturation of 92% during the next 3 days.

Keywords: gvhd prochymal graft vs host disease
non invasive brain stimulation treatment for clbp

Conditions: Chronic Low Back Pain (CLBP)

Summary: this trial is designed to preliminary evaluate the efficacy and safety of nibs system for treatment of chronic low back pain (clbp) (over 6 months). the trial is of a double blind sham controlled partial crossover design and will involve 2 weekly treatments and evaluations for 6 weeks, with 6 weeks follow-up. the goal of the study is to 1. asses the clbp change immediate and long term effect for the trial duration and follow-up. 2. asses quality of life improvement as measure by sleep quality and questioners. 3. asses long term neuronal changes or lack thereof in treated and untreated subjects.


Eligibility criteria:
inclusion criteria: * age 18 to 80 * clbp as defined by the european guidelines. * low back pain first week average nprs\>4. exclusion criteria: 1. acute low back pain (duration of less than 6 months) first week average nprs\> 4 2. neurological illness causing structural brain damage (e.g. stroke, tia) 3. psychiatric disease other than mood disorders 4. current chronic use of medications with pro-epileptic properties 5. known alcohol dependency 6. use of alcohol within the previous 24 hours 7. history of loss of consciousness 8. epilepsy or epilepsy in a first degree relative 9. medical implants 10. pregnancy 11. illicit drug use or within the previous month
exosome testing as a screening modality for human papillomavirus-positive oropharyngeal squamous cell carcinoma

Conditions: Oropharyngeal Cancer

Summary: cancer of the oropharynx (middle, side and back walls of the throat; back of the tongue; soft palate, and tonsils), or oropharyngeal squamous cell carcinoma (opscc), has been on the rise in the united states. human papillomavirus (hpv) has been recognized in many of these cancers, and testing for hpv has contributed to the higher reported rates of opscc. in this study, our goal is to develop a new test that can detect certain hpv proteins in the blood or saliva to help improve detection of opscc.

while secondary screening strategies have successfully reduced the rate of hpv-positive cervical cancers, an effective screening modality for hpv-opscc does not exist. a central problem in the early diagnosis of hpv-opscc is the relative inaccessibility of the tonsillar crypts, where oncogenic infections are thought to originate. unlike the relatively smooth surface of the cervix which permits mechanical sampling with pap tests and which can be evaluated visually for evidence of dysplasia, much of the tonsillar epithelium is found below the surface in a complex network. as a consequence, any screening modality cannot depend upon direct access to malignant lesions. what is needed is a minimally invasive, diffusible or circulating marker of hpv-opscc, and a means to collect and detect it.

Eligibility criteria:
inclusion criteria (cancer patients): * male or female * age greater than or equal to 18 * previously untreated, pathologically confirmed opscc (hpv+ or hpv-) * ability to understand study information and provide written consent for participation. inclusion criteria (non-cancer patients): * male or female * age greater than or equal to 18 * ability to understand study information and provide written consent for participation exclusion criteria: * age less than 18 years * prisoners * pregnant women * patients with mental disability

Keywords: head and neck cancer throat cancer human papillomavirus hpv exosome diagnostic early detection
rivaroxaban safety profile in the prophylaxis of venous thromboembolism after hip fracture surgery

Conditions: Open Fracture of Hip

Summary: arterial and venous thromboembolism represents one of the most common preventable health problems. patients undergoing surgery, especially hip fracture surgery are at high risk for deep vein thromboembolism (vte) without thromboprophylaxis. in the absence of prophylaxis, the incidence of fatal pulmonary embolism (pe) after hip fracture surgery (hfs) is reportedly 4%-12%. provision of thromboprophylaxis to all patients who undergo hfs is recommended.

rivaroxaban is the first agent of a new class of drugs acting as direct factor xa inhibitors with oral bioavailability. highly selective inhibition of factor xa by rivaroxaban is expected to inhibit the amplified burst of thrombin generation and may result in more effective inhibition of thrombus formation with a favorable safety profile. in thailand rivaroxaban is indicated for the prevention of vte in patients undergoing major orthopedic surgery of the lower limbs including surgery for hip fractures. there are limited number of observational studies of rivaroxaban in thromboembolism after hip fracture surgery as the approved indication in most countries are for thromboprophylaxis in hip and knee arthroplasty. the broader indications and the high number of hip fracture surgeries in thailand allow us to explore a pattern of safety profile particularly bleeding complications and risk factors in patients receiving rivaroxaban thromboprophylaxis after hip fracture surgery.

Eligibility criteria:
inclusion criteria: * at least 50 years old in men or post-menopause in women * patients, who are undergoing standard surgery for fracture of the upper third of the femur, including femoral head, neck, trochanteric and sub-trochanteric fracture and the surgery is planned within 7 days after admission * patients, who are eligible for thromboprophylaxis. such patients will be enrolled only after physician's decision to prescribe rivaroxaban for thromboprophylaxis has been made. the decision is totally based on standard of medical practice. * patients, who agree to participate, return to follow-up visits, and who have signed informed consent to participate in the study. exclusion criteria: * trauma affecting more than 1 organ system * pathological fracture secondary to malignant disease * clinically significant bleeding excluding drainage * documented congenital or acquired bleeding disorder * patients, who have contraindications for thromboprophylaxis or contraindications to take rivaroxaban according to fda-approved product label * patient on oral anticoagulation therapy in the past 7 days * pregnancy or breastfeeding * patients who are simultaneously participating in a different study
a study to evaluate the benefit of octagam 5%® in subjects with pediatric acute-onset neuropsychiatric syndrome (pans)

Conditions: Pediatric Acute-Onset Neuropsychiatric Syndrome; Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections

Summary: this study will evaluate the use of intravenous immunoglobulins (ivig) at a dose of 1g/kg/body weight given every three weeks for 6 infusions in pediatric subjects ages 4 - 16 years with moderate to severe pans. the study will compare biomarkers and behavioral scales before treatment, after the last infusion, 2 months, and at a minimum 6 months post-treatment.

ivig at an immunomodulatory dose of 1 g/kg body weight has been known to induce suppression of systemic inflammation and has been used in the treatment of autoimmune diseases. it has been proven beneficial in inflammatory conditions affecting the nervous system.

Eligibility criteria:
inclusion criteria: * male and female children, 4-16 years of age * diagnosis of moderate to severe pans based on accepted criteria * must be willing to follow study procedures and comply with wash-out period * if using prophylactic antibiotics, must be on stable dose for 3 months exclusion criteria: * history of rheumatic fever, including sydenham chorea (the neurologic manifestation) * previous ivig therapy within the last 6 months * allergic reactions to blood products * patients who, in the investigator's opinion, might not be suitable for the trial. * steroid use

Keywords: obsessive-compulsive disorder anxiety pans pandas children